HEALEY ALS Platform Trial - Regimen A Zilucoplan

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen A will evaluate the safety and efficacy of a single study drug, zilucoplan, in participants with ALS.

Key facts

Study ID

NCT04436497

Run by

Merit E. Cudkowicz, MD

People needed

162

Starts

2020-07-29

Expected to finish

2022-05-04

Last updated by the study team

2023-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The following inclusion criterion is in addition to the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
• Vaccination with a quadrivalent meningococcal vaccine and meningococcal serotype B vaccine at least 14 days prior to the first dose of study drug at the Baseline (Day 0) visit. Meningococcal vaccines (including boosters) should be administered in accordance with the study's vaccination worksheet.

You may not qualify if…

• The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
• History of meningococcal disease.
• Prior treatment with a complement inhibitor.

Where it is running

• Healey Center for ALS at Mass General — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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